Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00819013

First received: October 10, 2008

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2008

Last Updated Date

January 16, 2012

Start Date ^ICMJE

July 2007

Primary Completion Date

January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. [ Time Frame: Day 0 through Day 60 post-vaccination ]
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 through Day 7 post-vaccination ]
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 through Day 60 post-vaccination 1 ]
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ]
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ]
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).

A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

Original Primary Outcome Measures ^ICMJE

Safety and reactogenicity of ACAM-FLU-A with and without adjuvant compared to placebo control in healthy adult subjects. [ Time Frame: one and one half years ]

Change History

Complete list of historical versions of study NCT00819013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Month 4 through Month 10 post-vaccination 1 ]
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).

A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 15 through Month 10 post-vaccination 1 ]
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 15 through Month 10 Post-vaccination 1 ]
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.

Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods

Original Secondary Outcome Measures ^ICMJE

Immunogenicity profile following two doses of ACAM-FLU-A with and without adjuvant compared to placebo control. [ Time Frame: one and one half years ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

Official Title ^ICMJE

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults

Brief Summary

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

Detailed Description

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Influenza

Intervention ^ICMJE

Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular

Other Name: ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular

Other Name: ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular

Other Name: ACAM FLU-A
Biological: Saline placebo
0.5 mL, Intramuscular

Other Name: USP Saline

Study Arms

Experimental: Study Group 1
ACAM-FLU-A low dose + Adjuvant 1

Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
Experimental: Study Group 2
ACAM-FLU-A low dose + Adjuvant 2

Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
Experimental: Study Group 3
ACAM-FLU-A low dose

Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
Placebo Comparator: Study Group 4
Saline placebo

Intervention: Biological: Saline placebo

Publications *

Ibañez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

January 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria:

Known allergies or severe reactions to any of the vaccine components including those to adjuvants
History of severe allergic reactions, including angioedema;
History of asthma or recurrent wheezing; (current or within past 2 years);
History of neurological symptoms or signs following administration of any vaccine;

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00819013

Other Study ID Numbers ^ICMJE

H-261-001

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Sanofi Pasteur Inc

PRS Account

Sanofi

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top